This company now offers reagents for detecting Flavavirus (West Nile Virus) antibodies using a recombinant protein antigen licensed from the Centers for Disease Control and Prevention (CDC). Two different ASR package configurations are available to detect Flavivirus (West Nile) IgM and IgG antibodies. The first, an antigen pack, will be made available exclusively to public health laboratories exclusively as a replacement for antigen previously supplied by CDC. The second, IgG and IgM reagent packs, will be available to commercial laboratories and hospitals as well as public health facilities.
     A 510(k) submission is planned once data from formal clinical trials is complete, anticipated in Summer 2003. In addition, this company will continue to perform WNV testing in its own reference laboratory, using the same products it is making available to other laboratories.
     Laboratory diagnosis of WNV infection is through detection of IgM and/or IgG antibodies to WNV in serum. Positive detection of WNV IgM antibodies is confirmed using neutralization (PRNT). Viral detection using PCR is also available. PCR is highly specific but may not yield positive results at the time patients show clinical symptoms.
Focus Technologies
www.CLPmag.com
Keywords: infectious disease, WNV